An observational study in Acute Kidney Injury (AKI), sponsored by University Hospital Muenster. Completed at 82 sites in 14 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-21.
Sponsored by University Hospital Muenster · Observational
The evaluation of an accurate occurrence rate for AKI is of great importance for health policy, quality initiatives as well as for designing clinical trials.
The primary objective is to prospectively evaluate the incidence of AKI within 72 h after extended surgical procedures that require admission to an observation unit.
Acute kidney injury (AKI) is a severe clinical complication with increasing incidence and is associated with adverse short- and long-term outcomes resulting in a major health care burden worldwide. The introduction of consensus classification systems has enhanced the awareness for AKI. The evaluation of an accurate occurrence rate for AKI is of great importance for health policy, quality initiatives as well as for designing clinical trials. However, analyzing AKI from existing databases is often limited by missing data elements, especially the inclusion of the urine output criteria. Missing data and the use of different definitions before the consensus classification are the reasons for large variations in reported occurrences of surgical induced AKI.
The primary objective is to prospectively evaluate the incidence of AKI within 72 h after extended surgical procedures that require admission to an observation unit (e.g., Intensive Care Unit, Intermediate Care, Post Anesthesia Care Unit) using the latest consensus definition for AKI (Kidney Disease: Improving Global Outcomes criteria) and a standardized data collection instrument and to assess the dependence of AKI on preoperative and intraoperative factors.
Method: International prospective, observational, multi-center, cross-sectional cohort study
Eligible patients will be identified during preoperative assessment. All eligible patients will be approached to obtain written consent.
1,691 studies on the registry are indexed under Acute Kidney Injury; 395 are open to participants now.
This study's enrollment of 10,568 is above the median of 160 across 814 observational studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →University Hospital Muenster is the lead sponsor of 192 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients undergoing extended surgical procedure and the need for postoperative observation
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with extended surgical exposures requiring postoperative observation.
Incidence of Acute Kidney Injury
Occurrence of acute kidney injury according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria
Time frame: 72 hours after extended surgery
Severity of acute kidney injury (number of patients with KDIGO stage 1, KDIGO stage 2 or KDIGO stage 3)
Definition and classification of acute injury according to the KDIGO (Kidney Disease: Improving Global Outcomes) clinical practice guidelines on acute kidney injury
Time frame: 72 hours after extended surgery
Number of patients with renal replacement therapy
Time frame: up to 90 days after extended surgery
Mortality
Time frame: up to 90 days after extended surgery
Hospital stay
Time frame: up to 90 days after extended surgery (until discharge)
Intensive Care Unit stay
Time frame: up to 90 days after extended surgery (until discharge)
Major Adverse Kidney Events (MAKE)
combined endpoint consisting of mortality, renal replacement therapy, persistent renal dysfunction defined as serum-creatinine \>= 1.5 times as compared to baseline serum-creatinine
Time frame: up to 90 days after extended surgery
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jun 2020 to primary completion in Feb 2022, 20 months.
Of 349 non-industry observational studies under Acute Kidney Injury, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 42. This study's 20 months is below that.
Counting every sponsor, half of 364 studies reached it within 24 months; a quarter within 12 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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